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Explanation of Consent Form standards by Committee of Human Research, UCSF

As part of the Committee on Human Research (CHR) process improvement project analysis, we discovered that poorly-prepared submissions negatively impacted the review and approval times of well-prepared submissions by diverting significant time and resources to a small fraction of poorly prepared submissions. Consequently, the CHR office is implementing consistent minimum submission standards. Instituting this new procedure will enable CHR staff to focus on well-prepared applications, resulting in faster reviews and approvals overall.
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Using Systems Thinking and Tools to Solve Public Health Problems

Public health researchers and practitioners often work to solve complex population and health issues, such as obesity and chronic disease, which are deeply embedded within the fabric of society. As such, the solutions often require intervention and engagement with key stakeholders and organizations across many levels ranging from local entities (schools, churches, and work environments) to regional systems (health departments and hospital networks) to entire countries (national agencies). This multi-level, multi-participant view is at the heart of systems thinking, a process of understanding how parts influence one another within a whole.
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Focus Group Questions for Sexual Negotiations

The following two outlines of focus group questions are taken from the Sexual Negotiations among Young Adults in the Era of AIDS research study. Prepared by Diane Binson, PI. Funded by the Universitywide AIDS Research Program, R94-SF-050. Instruments:

Scoring: N/A Reliability and/or validity: N/A

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Crack cocaine

What are the HIV prevention needs of crack cocaine users?

Prepared by Margaret R. Weeks PhD, Institute for Community Research and Pamela DeCarlo, CAPS Fact Sheet 66, December 2009

Is crack cocaine an issue?

Yes. Although many people think of it as a drug of the 80s, crack cocaine is still around. HIV prevention has traditionally focused on injecting drug use and other stimulants like methamphetamine. But many people use more than one drug and may be using these drugs in different ways, for example, smoking crack and injecting heroin. Crack use alone and crack use combined with other drugs present real risks for HIV transmission and acquisition. Crack cocaine is a powerfully addictive stimulant drug. Crack is a rock crystal, which can be smoked or dissolved and injected. It is relatively cheap and readily available on the street in mainly low-income urban areas. Crack is highly addictive and the effects of the drug are short-lived (about 5 minutes), making it necessary to use more to maintain a high. Recent studies of crack users show high rates of HIV infection. In Harlem, New York, 23.9% of users and sellers of crack were HIV+1; in Los Angeles, California, 24% of older low-income MSM were HIV+2; and 22.4% of female street sex workers in Miami, Florida were HIV+3.

Who uses crack?

While crack use may vary geographically by race, age and sexual orientation, most crack use is concentrated in inner city communities that are impoverished and disadvantaged and have limited access to many services. These are the same neighborhoods with high rates of unemployment, homelessness, violence, substance abuse, HIV, sexually transmitted diseases (STDs) and other risks. However, some crack users do not fit these characteristics and are still at very high risk of health related consequences of crack use.

How does crack affect HIV transmission risk?

Risk of HIV and other sexually transmitted diseases can vary by level of crack use and addiction. Crack’s short-lived high and addictiveness can create a compulsive cycle in which users quickly exhaust their resources and turn to other ways to get the drug, including exchanging sex for money or drugs (such as a “hit” of crack)4. Trading sex in these circumstances often creates extremely risky situations that may include high numbers of partners, sex while under the influence and drug-related violence. This environment makes it hard to engage in safer behaviors and contributes to inconsistent condom use.5,6 In one study, HIV infection was associated with intensive, daily crack smoking among women engaged in survival sex.5,7 Crack use is also associated with very high rates of other STDs, including syphilis, gonorrhea, and chlamydia. Lesions and abrasions associated with these infections increase opportunities for infection with HIV, especially during repeated or protracted sex, common among crack users.8 Crack is often smoked in make-shift pipes that use a glass pipette (tube) or a broken car antenna as a mouthpiece. These crack pipes can lead to cuts and burns on the lips, which are associated with HIV transmission.9 It is not known if this is due to sharing pipes between users or sexual transmission during oral sex. Some research shows possible risk of pneumonia and tuberculosis transmission through sharing of crack pipes as well.10

How does crack affect HIV+ persons?

Crack use affects HIV+ persons on many levels: biological, social and behavioral. On a biological level, crack use can accelerate HIV disease progression.11 One study found that persistent crack users were over three times as likely to die from AIDS-related causes as non-users.12 On a social level, most crack users who are HIV+ live in disadvantaged and impoverished communities, which present a variety of barriers to health. Crack users with HIV are less likely than HIV+ non-users to have access to basic medical services and more likely never to have been in HIV primary care.13 They are less likely to have a regular healthcare provider and to initiate medical care and treatment.14 On a behavioral level, crack users have low rates of adherence to HIV therapy once they have begun treatment.15 And HIV+ crack users are more likely than HIV+ non-users to continue to engage in high risk sexual behaviors with HIV- or unknown status partners after learning their HIV status.13

What’s being done?

The Risk Avoidance Partnership (RAP) Project in Hartford, Connecticut, trained active drug injectors and crack users to deliver an HIV, hepatitis, and STD prevention intervention to hard-to-reach drug users both inside and outside of their networks. The Peer Health Advocates (PHAs) received training in risk reduction and health promotion, communication skills and the importance of health advocacy. Crack users in RAP helped to design special “crack kits” they distributed to encourage use of rubber tips on crack pipes; kits also included male and female condoms and “dental dams” (flat latex sheets for use when performing oral sex on women). Study participants reported significant risk reduction.16 Using a harm reduction model, a needle exchange program in Ottawa, Canada distributes safety kits to crack users to reduce the risk of cuts and burns and potential transmission from sharing crack pipes and to decrease needle sharing. The kits include glass stems, rubber mouthpieces, brass screens, chopsticks, lip balm and chewing gum. Recipients reported less injecting and less sharing of pipes.10,17 JEWEL (Jewelry Education for Women Empowering their Lives) was an economic empowerment and HIV prevention project for crack-using women involved in prostitution in Baltimore, Maryland. The JEWEL intervention used six 2-hour sessions that taught HIV prevention and the making, marketing and selling of jewelry. Women participants significantly reduced trading drugs or money for sex, the number of sex trade partners, and daily crack use.18 Two separate intervention trials compared a standard National Institute on Drug Abuse HIV prevention intervention to woman-focused, culturally-specific interventions for female African-American crack cocaine users. The two interventions were grounded in motivation and empowerment theories and addressed the reality of the daily lives of women and the violence and poverty of their inner-city neighborhoods. Women in the culturally-specific interventions reported more reductions in sexual risk behaviors19 as well as improvements in employment and housing status.20

What still needs to be done?

While there is still no medical treatment for crack or cocaine abuse and dependence, several behavioral treatments have demonstrated efficacy for helping people to initiate abstinence and to prevent relapse to cocaine use. These include contingency management, cognitive behavioral therapy, and motivational interviewing.21 Currently available treatment for crack dependence tends to be limited to 12-step programs, which have little evidence of efficacy. Further development and testing of efficacious behavioral and medical treatments are needed to help crack users overcome the intense cravings associated with crack addiction. Federal sentencing laws currently give far harsher penalties for crack cocaine than for powdered cocaine.22 Using a 100-to-1 ratio, a person who sells a small amount of crack receives the same sentencing as a person who sells 100 times that amount of powder cocaine, resulting in prisons packed with low-level, predominantly African American offenders. In 2008, over 80% of offenders sentenced for crack-related federal crimes were Black and 10% were White. Activists and legislators are working to change the legislation, and to make it retroactive for those currently incarcerated.23 Stronger public policy around sentencing guidelines are needed. Substance use is complicated and HIV prevention has tended to simplify efforts into either reducing needle sharing and needle use, or reducing sexual risk. However, many IDUs also use crack, and often smoke crack when they’ve stopped injecting. Programs for IDUs should address poly-drug use, including crack use, and sexual risk reduction in the context of complex psychological and social needs and pressures associated with addiction. Crack users face a variety of barriers to remaining healthy, and programs need to take a more holistic approach to prevention.24 Crack users often need basic services such as childcare, safe shelter, food security, basic necessities and substance abuse treatment before they can think about HIV prevention.25 Interventions should not simply focus on drug and sex risks, but should address these basic survival needs as well as education, employment, housing and job training.


Says who?

1. Davis WR, Johnson BD, Randolph D , et al. Risks for HIV infection among users and sellers of crack, powder cocaine and heroin in central Harlem: Implications for interventions. AIDS Care. 2006;18:158-165. 2. Ober A, Shoptaw S, Wang PC, et al. Factors associated with event-level stimulant use during sex in a sample of older, low-income men who have sex with men in Los Angeles. Drug & Alcohol Dependence. 2009;102:123-129. 3. Inciardi JA, Surratt HL, Kurtz SP. HIV, HBV, and HCV infections among drug-involved, inner-city, street sex workers in Miami, Florida. AIDS and Behavior.2006;10:139-147. 4. Edwards JM, Halpern CT, Wechsberg W. Correlates of exchanging sex for drugs or money among women who use crack cocaine. AIDS Education and Prevention. 2006;18:420-429. 5. Sharpe TT. Behind the eight-ball: Sex for crack cocaine exchange and poor Black women. Taylor and Francis, New York. 2005 6. Sterk CE, Elifson KW, Theall KP. Individual action and community context: The health intervention project. American Journal of Preventive Medicine.2007;32:S177-S181. 7. Shannon K, Bright V, Gibson K, et al. Sexual and drug-related vulnerabilities for HIV infection among women engaged in survival sex work in Vancouver, Canada.Canadian Journal of Public Health. 2007;98:465-469. 8. Miller M, Liao Y, Wagner M, et al. HIV, the clustering of sexually transmitted infections, and sex risk among African American women who use drugs. Sexually Transmitted Diseases. 2008;35:696-702. 9. Theall KP, Sterk CE, Elifson KW, et al. Factors associated with positive HIV serostatus among women who use drugs: continued evidence for expanding factors of influence. Public Health Reports. 2003;118:415-424. 10. Johnson J, Malchy L, Mulvogue T, et al. Lessons learned from the SCORE project: A document to support outreach and education related to safer crack use. June 2008. 11. Baum MK, Rafie C, Lai S, et al. Crack-cocaine use accelerates HIV disease progression in a cohort of HIV-positive drug users. Journal of AIDS. 2009;50:93-99. 12. Cook JA, Burke-Miller JK, Cohen MH, et al. Crack cocaine, disease progression, and mortality in a multicenter cohort of HIV-1 positive women. AIDS. 2008; 22:1355-1363. 13. Metsch LR, Bell C, Pereyra M, et al. Hospitalized HIV-infected patients in the era of highly active antiretroviral therapy. American Journal of Public Health. 2009;99:1045-1049. 14. Cunningham CO, Sohler NL, Berg KM, et al. Type of substance use and access to HIV-related health care. AIDS Patient Care and STDs. 2006; 20:399-407. 15. Moss AR, Hahn JA, Perry S, et al. Adherence to highly active antiretroviral therapy in the homeless population in San Francisco: a prospective study.Clinical Infectious Diseases. 2004;39:1190-1198. 16. Weeks MR, Li J, Dickson-Gomez J, et al. Outcomes of a peer HIV prevention program with injection drug and crack users: the Risk Avoidance Partnership.Substance Use & Misuse. 2009;44:253-281. 17. Leonard L, DeRubeis E, Pelude L, et al. “I inject less as I have easier access to pipes” Injecting, and sharing of crack-smoking materials, decline as safer crack-smoking resources are distributed. Int’l Journal of Drug Policy. 2008; 19:255-264. 18. Sherman SG, German D, Cheng Y, et al. The evaluation of the JEWEL projects: An innovative economic enhancement and HIV prevention intervention study targeting drug using women involved in prostitution. AIDS Care.2006;18:1-11. 19. Sterk CE, Theall KP, Elifson KW, et al. HIV risk reduction among African-American women who inject drugs: a randomized controlled trial. AIDS and Behavior. 2003;7:73-86. 20. Wechsberg WM, Lam WK, Zule WA, et al. Efficacy of a woman-focused intervention to reduce HIV risk and increase self-sufficiency among African American crack abusers. American Journal of Public Health. 2004;94:1165-1173. 21. National Institute on Drug Abuse. Research Report Series. Cocaine: Abuse and Addiction. May 2009. 22. Sentencing. Stiff sentence for HIV+ crack user affirmed on appeal. AIDS Policy & Law. 2007;22:8. 23. Emery T. Will crack-cocaine sentencing reform help current cons? Time Magazine. August 7, 2009. 24. Schlabig Williams J. Researchers adapt HIV risk prevention program for African-American women. NIDA Notes. April 2004. 25. MacMaster SA. Social service delivery preferences among African American women who use crack cocaine: What women say they need before they can be open to HIV prevention services? Journal of HIV/AIDS & Social Services.2006;5:161-179.


Special thanks to the following reviewers of this Fact Sheet: Susan Boyd, Michael Campsmith, Judith Cook, Tom Donohoe, Waleska Maldonado, Lisa Metsch, Kate Shannon, Steve Shoptaw, Claire Sterk, Bill Stewart, Tanya Telfair Sharpe. Reproduction of this text is encouraged; however, copies may not be sold, and the University of California San Francisco should be cited as the source. Fact Sheets are also available in Spanish. To receive Fact Sheets via e-mail, send an e-mail to listserv@listserv.ucsf.edu with the message “subscribe CAPSFS first name last name.” ©December 2009, University of CA. Comments and questions about this Fact Sheet may be e-mailed to CAPS.Web@ucsf.edu.

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HIV+ persons

What are HIV+ persons’ HIV prevention needs?

revised 9/05

do HIV+ persons need prevention?

Yes. Over 1 million persons in the US are living with HIV/AIDS.1 Advances in the early diagnosis, treatment and care of HIV+ persons have helped many people enjoy increased health and longer life. Some HIV+ persons have experienced a renewed interest in sexual or drug-using activity. This can place them at risk for acquiring additional STD infections and for transmitting HIV to their uninfected partners.2 Many HIV+ persons, therefore, require programs to help them stay safe. Most HIV+ persons are concerned about not infecting others and make efforts to prevent transmission.3 However, a significant percentage of HIV+ persons struggle with prevention: from 20-50% of HIV+ persons report unprotected sex with partners who are HIV- or whose HIV status they do not know. For many HIV+ persons, the same structural, inter-personal and behavioral challenges that put them at risk for HIV persist beyond their HIV diagnosis and play a role in their inability to prevent HIV transmission.4 Prevention with HIV+ persons may include education and skills building interventions, efforts to test more persons who are HIV+ but do not know their status, support and testing for partners of HIV+ persons and integrating prevention into routine medical care.5

how is it different?

HIV prevention programs with HIV+ persons are different than programs with HIV- persons in that they must address clinical, mental and social support needs as well as build skills to prevent HIV transmission to current and future partners. Stigma. Pre-existing stigma towards gay men, women, drug users, sex workers and persons of color has helped fuel the HIV epidemic in this country by creating social conditions that foster HIV transmission.6 Added to this is the additional stigma of living with HIV. Previous experience of stigma (coming out as gay or as a drug user) may lead to trauma that impacts the ability to cope with HIV transmission.7 It is important to address these structural factors to build strength and resiliency in HIV+ communities. Disclosure. One of the foremost concerns for HIV+ persons is how, when, where and to whom to disclose their HIV status.8 The traditional message has been that HIV+ persons should always disclose their HIV status to partners. In reality, disclosure is complex and difficult. Some HIV+ persons decide not to disclose and not engage in risk behavior. HIV+ persons often fear that disclosure may bring partner or familial rejection, limit sexual opportunities or increase risk for physical and sexual violence. A survey of HIV+ persons found that 42% of gay men, 19% of heterosexual men and 17% of women had sex without disclosing their HIV status.9 HIV+ persons may disclose differently with doctors, family, friends, work colleagues and sexual and injecting partners. Responsibility. Persons with HIV live with both the experience of being infected (sometimes by someone they love and trust) and the tremendous responsibility of knowing that they can infect other people. Although the subject of responsibility is complex, prevention programs can provide support to HIV+ persons to explore and understand what it means for them individually.10

what can HIV+ persons do?

Many HIV+ persons are using strategies that limit HIV transmission. One strategy is having sex mainly with other known HIV+ persons.11 Knowing that your sexual partner is also HIV+ avoids the risk of transmission and allows for sex without consistent condom use. There have been recent concerns about superinfection among HIV+ couples, where one HIV+ person might acquire another strain of HIV from their HIV+ partner. However, superinfection among such couples appears to be rare.12 Another strategy is switching from high-risk to lower risk activities. HIV+ persons can avoid high-risk activities such as being an insertive partner (top) during anal and vaginal sex, having sex while menstruating, breastfeeding and sharing syringes. Lower risk activities can be having oral sex and being a receptive partner (bottom).11

what can my agency/clinic do?

HIV+ persons are a diverse group and require prevention programs that fit their specific needs. Programs need to see the whole person, not just sex and drug use. Relationships, employment, healthcare, housing, stigma and discrimination should be addressed as needed. Listening to HIV+ persons and involving them in the design, delivery and evaluation of programs ensures that programs are relevant and useful.13 Prevention programs with HIV+ persons can require institutional change and adjustment for agencies and clinics that may be integrating care and prevention services for the first time. Healthcare clinics may train providers and staff to deliver prevention counseling, link with prevention and social service agencies or provide referrals to agencies. Prevention programs may train staff in treatment and care issues, forge relationships with clinics and service agencies or provide referrals. It is critical for healthcare providers to maintain a non-judgmental tone about situations and behaviors with HIV+ clients.14 It is equally important to work in collaboration with HIV+ persons to develop a concrete risk reduction plan based on the client’s needs and abilities.14 Providers should be supportive, empathic, goal-oriented and focus on a client’s strengths and resiliencies. Prevention programs need to provide clients with the knowledge, skills and resources (such as condoms, clean needles and a plan to decrease alcohol and drug use) to put the risk reduction plan in place.

what’s being done?

There are currently many programs and interventions addressing prevention with HIV+ persons in service agency and clinical settings across the US. The following programs are part of the CDC’s Replicating Effective Programs initiative.15 Healthy Relationships is a five-session risk-reduction group intervention for men and women. The program focuses on developing decision-making and problem-solving skills for making informed and safe decisions about disclosure and behavior. The groups allow HIV+ persons to interact, examine their risks, develop skills to reduce their risks and receive feedback from others. Participants reported significantly less unprotected intercourse and greater condom use at six-month follow-up.16 Choosing Life: Empowerment, Action, Results (CLEAR) offers HIV+ youth 18 one-on-one 90-minute sessions with a counselor. CLEAR seeks to build motivation and enhance self-esteem so that youth can learn to choose healthy activities over self destructive behaviors. CLEAR is divided into three modules: substance use, sexual decision-making and self care. Youth also can choose telephone sessions instead of in person sessions. Youth participating reported having fewer sexual partners, using fewer drugs and feeling less emotional distress.17 CLEAR is now known as Street Smart. Partnership for Health trained staff in HIV medical clinics to provide brief, safer-sex counseling supplemented by written information and clinic posters. The program found that counseling emphasizing the negative consequences of unsafe sex helped reduce risky behaviors with patients who reported 2 or more partners.18

what needs to be done?

Prevention programs with HIV+ persons need to pay attention to structural barriers to safer sexual and drug use behavior. For some HIV+ persons, barriers may include housing instability, lack of access to HIV care and repeated incarceration. The challenges of sexual and drug risk behavior, disclosure and responsibility need to be placed in social and structural contexts that are meaningful to HIV+ persons. There is a need to further examine how early childhood and adult trauma, sexual abuse, coming out, racism and homophobia affect an HIV+ person’s ability to maintain safer behaviors. More emphasis should be placed on couples and sexual partners, both in research and in prevention programs, because sexual risk behavior among HIV+ persons is often a shared risk decision within couples/partners.19 Prevention with positives programs present the opportunity and challenge of forging relationships and integrating services in areas that have not traditionally worked together. Treatment, prevention and social services need to work in tandem, helping clients deal with the multiple issues they may face. Involving HIV+ persons is key. Prepared by Kelly Knight MEd and Carol Dawson-Rose RN PhD, CAPS


Says who?

1. Glynn M, Rhodes P. Estimated HIV prevalence in the United States at the end of 2003. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #595. 2. Janssen RS, Valdiserri RO. HIV prevention in the Unites States: increasing emphasis on working with those living with HIV. Journal of AIDS. 2004;37:S119-S121. 3. Marks G, Crepaz N, Senterfitt JW, et al. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States. Journal of AIDS. 2005;39:446-453. 4. Crepaz N, Marks G. Towards an understanding of sexual risk behavior in people living with HIV: a review of social, psychological and medical findings. AIDS. 2002;16:135-149. 5. Centers for Disease Control and Prevention. Advancing HIV prevention: new strategies for a changing epidemic – United States, 2003. Morbidity and Mortality Weekly Report. 2003;52:329-332. 6. Herek GM, Capitanio JP, Widaman KF. Stigma, social risk, and health policy: public attitudes toward HIV surveillance policies and the social construction of illness. Health Psychology. 2003;22:533-540. 7. Knight KR. With a little help from my friends: community affiliation and perceived social support. In HIV+ Sex. PN Halkitis, CA Gómez, RJ Wolitsky, eds. American Psychological Association; Washington DC. 2005. 8. Parsons JT, Missildine W, Van Ora J, et al. HIV serostatus disclosure to sexual partners among HIV-positive injection drug users. AIDS Patient Care and STDs. 2004;18:457-469. 9. Ciccarone DH, Kanouse DE, Collins RL, et al. Sex without disclosure of positive HIV serostatus in a US probability sample of persons receiving medical care for HIV infection. American Journal of Public Health. 2003;93:949-954. 10. Wolitski RJ, Bailey CJ, O’Leary A, et al. Self-perceived responsibility of HIV-seropositive men who have sex with men for preventing HIV transmission. AIDS and Behavior. 2003;7:363-372. 11. Parsons JT, Schrimshaw EW, Wolitski RJ, et al. Sexual harm reduction practices of HIV-seropositive gay and bisexual men: serosorting, strategic positioning, and withdrawal before ejaculation. AIDS. 2005;19:S13-S25. 12. Grant RM, McConnell JJ, Herring B, et al. No superinfection among seroconcordant couples after well-defined exposure. Presented at the International Conference on AIDS. 2004. Abst #ThPeA6949. 13. National Association of People with AIDS. Principles of HIV prevention with positives. www.napwa.org/pdf/PWPPrinciples.pdf (Accessed 4/20/06) 14. Dawson-Rose C, Shade SB, Lum P, et al. The healthcare experience of HIV positive injection drug users. Journal of Multicultural Nursing and Health. 2005;11:23-30. 15. https://www.cdc.gov/hiv/effective-interventions/index.html (Accessed 4/20/06) 16. Kalichman SC, Rompa D, Cage M, et al. Effectiveness of an intervention to reduce HIV transmission risks in HIV-positive people. American Journal of Preventive Medicine. 2001;21:84-92. 17. Rotheram-Borus MJ, Swendeman D, Comulada WS, et al. Prevention for substance-using HIV-Positive young people: telephone and in-person delivery. Journal of AIDS. 2004;37:S68-S77. 18. Richardson JL, Milam J, McCutchan A, et al. Effect of brief safer-sex counseling by medical providers to HIV-1 seropositive patients: A multi-clinic assessment. AIDS.2004;18:1179-1186. 19. Remien RH, Wagner G, Dolezal C, et al. Factors associated with HIV sexual risk behavior in male couples of mixed HIV status. Journal of Psychology and Human Sexuality. 2001;13:31-48.


September 2005. Fact Sheet #37ER Special thanks to the following reviewers of this Fact Sheet: Latoya Conner, Keith Folger, Mari Gasiorowicz, Trevor Hart, Gregory Herek, Jessica Merron-Brainerd, Katie Mosack, Judith Moskowitz, Lisa Orban, Robert Remien, Kurt Schroeder, Stephen Trujillo, Tim Vincent.


Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Franciso should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National Prevention Information Network at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to CAPS.web@ucsf.edu. ©Sepetmber 2005, University of California